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FDA 510(k)

PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY

K-Number: K850263 · 1985-03-25

ApplicantPlasmedics, Inc.
Decision Date1985-03-25
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Plasmedics, Inc.. It received FDA 510(k) clearance on 1985-03-25 under 510(k) number K850263. The device is classified under product code BSJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY?

PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY is a medical device that received FDA 510(k) clearance on 1985-03-25. The listed applicant is Plasmedics, Inc.. The 510(k) number is K850263.

When did PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY receive FDA 510(k) clearance?

PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY received FDA 510(k) clearance on 1985-03-25, under 510(k) number K850263.

Who is the listed applicant for PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY?

The FDA 510(k) record lists Plasmedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY?

The FDA product code for PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY is BSJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Plasmedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K853559STERILE BIOPSY NEEDLESK831601APNEA ALARM FOR ADULT-PEDIATRIC & NEONK831650ANESTHESIA/RESPIRATORY DISCONNECT -K830604WEDGE PRESSURE CATHETERK823351CENTRAL VENOUS CATHETER

Related Devices (Code: BSJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163277SuperNO2VA DeviceRevolutionary Medical Devices, Inc.K953107ANESTHESIA/RESPIRATORY FACE MASKMedical Marketing ConceptsK953295ANESTHESIA FACE MASKMallinckrodt MedicalK952689BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASKOwens-Brigam Medical Co.K951043AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASKPromedic, Inc.K950771DISPOSABLE ADHESIVE FACE MASKAdvanced Warming Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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